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Acalabrutinib

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Acalabrutinib does in the body

CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

From the FDA-approved label: Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK‑mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.

Why people take it. CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · I42748ELQW · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 182 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Enzyme

An enzyme is a protein that speeds up one chemical change.

A picture of it, and where the picture fails

An enzyme is like a machine on a production line doing one cut.

Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.

What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.

A catalytic protein that lowers the activation energy of a specific reaction.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Healthy ageingWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
all cause mortality

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

All-cause mortality

The study did not show it

Who was studied
NCT05024006
How many people
1314
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)

The study did not show it

Who was studied
NCT06136559
How many people
1200
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS

The study did not show it

Who was studied
NCT03836261
How many people
984
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Maximum Tolerated Dose (MTD)

The study did not show it

Who was studied
NCT03740529
How many people
803
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2

The study did not show it

Who was studied
NCT02972840
How many people
635
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B

The study did not show it

Who was studied
NCT04529772
How many people
611
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.7 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • maximum observed plasma concentration

Meaningful

Things that change how a life goes, not only a number.

  • event free survival
  • complete remission rate
  • all cause mortality
  • progression free survival
  • real world progression free survival
  • progress free survival
  • progression free survival by irc

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (32)
  • incidence of treatment emergent adverse events
  • part 1 incidence of treatment emergent adverse events
  • treatment emergent adverse events
  • grade 3 4 adverse events
  • grade 5 adverse events
  • any study drug related ae
  • grade 3 4 study drug related ae
  • grade 5 study drug related ae
  • any sae
  • grade 3 4 any sae
  • grade 5 any sae
  • any study drug related sae
  • overall response
  • overall response rate
  • experiencing dose limiting toxicities
  • complete response
  • response rate
  • adverse events
  • rate of undetected minimal residual disease
  • objective response rate

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of CALQUENCE in pediatric patients have not been established.”

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

  • On older people, the label states: “CLL and Previously Treated MCL Of the 1,758 CALQUENCE-treated patients with B-cell malignancies (excluding previously untreated MCL) in clinical trials, 1,074 (61%) were 65 years of age or older, and 341 (19%) were 75 years of age or older.”

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman.”

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production.”

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

  • On people with reduced liver function, the label states: “Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C).”

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S4.

No source is stored against this line.

What is in the pack

Sold as capsule, tablet, tablet, film coated, capsule, gelatin coated, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Acalabrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 129 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • malignant neoplasm progression — 24 reaction mentions
  • atrial fibrillation — 20 reaction mentions
  • febrile neutropenia — 17 reaction mentions
  • disease progression — 15 reaction mentions
  • drug resistance — 15 reaction mentions
  • covid-19 — 12 reaction mentions
  • leukocytosis — 9 reaction mentions
  • myelodysplastic syndrome — 6 reaction mentions
  • tumour lysis syndrome — 6 reaction mentions
  • lymphocytosis — 5 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 12 products list this as an active ingredient in the United States drug directory. 12 of them contain it and nothing else.

    FDA National Drug Code directory · 17228-4512 · read 2026-08-29

  • They are sold as capsule, gelatin coated, powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 17228-4512 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kinase inhibitor [epc] and tyrosine kinase inhibitors [moa].

    FDA National Drug Code directory · 17228-4512 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-29

  • CALQUENCE is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets:100 mg acalabrutinib, orange, oval, film-coated, biconvex, debossed with ‘ACA 100’ on one side and plain on the other., recorded as fda label in effect 2026-02-19 in the United States.

    US prescribing information · b1409184-3267-4d8c-8f17-4e01f69828b1 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Acalabrutinib studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Acalabrutinib are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 2 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same bioavailability, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
I42748ELQW
RxNorm concept
2607734

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 4 approved applications cover products containing this substance. The earliest was NDA210259, approved 20171031 to ASTRAZENECA.

    Drugs@FDA application register · NDA210259 · read 2026-08-29

  • Marketing status on the register: none (tentative approval) and prescription.

    Drugs@FDA application register · NDA210259 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20171031.

    FDA National Drug Code directory · 17228-4512 · read 2026-08-29

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Recorded evidence blocks (12)

What did Acalabrutinib's largest trial (15000 people) and its longest (14 years) measure?


15000 people in Acalabrutinib's largest registered study, 14 years in its longest registered window, measuring All cause Mortality. ClinicalTrials.gov · 2026-09-01

89 phase2, 43 phase1, 21 phase3, 4 na or unstated, 2 na, 2 phase4, 1 early phase1; NCT02180711; 2028-12-11; no ageing endpoint recorded. Last human test completed 2026, NCT05517265.

Interpretation These counts include studies where Acalabrutinib was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    89
  • phase1
    43
  • phase3
    21
  • na or unstated
    4
  • na
    2
  • phase4
    2
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT05517265
    2026-03-20

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Acalabrutinib shown lifespan?


mouse: mechanism-only and human: lifespan (142): the rungs where Acalabrutinib has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation All cause Mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat Dog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • human NCT04647669
    lifespan; All cause Mortality; 142

recorded 2026-09-01 · last checked 2026-09-04

12 of Acalabrutinib's trials stopped: futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


futility/efficacy (1), accrual/recruitment (2), funding/business (2), sponsor decision unspecified (4) and other (3): Acalabrutinib's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Sponsor Decision"; 12 of 142 registered studies

Show the evidence

Trial

  • NCT02570711
    terminated; "Sponsor Decision"
  • NCT03205046
    terminated; "Sponsor's decision not to pursue further development of the combination in DLBCL"
  • NCT03492125
    terminated; "The study is terminated due to major protocol revisions. A new study in CLL patients is planned."
  • NCT04016805
    terminated; "Strategic/Business decision"
  • NCT04189952
    terminated; "Investigator Decision"
  • NCT04337827
    terminated; "Slow accrual"
6 further recorded trials
  • NCT04497948
    terminated; "Data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19 did not meet their primary efficacy endpoints. Based on this higher management made the decision to prematurely terminate the D822FC00005 PK…"
  • NCT04660045
    withdrawn; "Company supplying drug/funding ceased support."
  • NCT04685915
    withdrawn; "Bayer is no longer funding due to lack of accrual"
  • NCT04836832
    withdrawn; "PI decision"
  • NCT05205252
    withdrawn; "Epizyme Inc. has revised the Tazemetostat development strategy and made the decision to terminate the hematological malignancies basket trial."
  • NCT06839872
    withdrawn; "AstraZeneca has made the decision to cancel the trial."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Acalabrutinib used Acalabrutinib 100 MG Oral Capsule — over how long?


studies of Acalabrutinib used the recorded amount. ClinicalTrials.gov · 2026-09-01

1 recorded entry; human; also "Acalabrutinib 100 MG Oral Capsule"

Show the evidence
  • human NCT04178798
    Acalabrutinib 100 MG Oral Capsule

recorded 2026-09-01 · last checked 2026-09-04

Which of adverse events, adverse events and serious adverse events and all cause mortality did Acalabrutinib's trials measure?


adverse events, adverse events and serious adverse events and all cause mortality lead 40 outcome terms across Acalabrutinib's trials. ClinicalTrials.gov · 2026-09-01

grade 3 4 adverse events, grade 5 adverse events, any study drug related ae, grade 3 4 study drug related ae, grade 5 study drug related ae and any sae follow.

Show the evidence
  • incidence of treatment emergent adverse events
    1
  • part 1 incidence of treatment emergent adverse events
    1
  • treatment emergent adverse events
    1
  • grade 3 4 adverse events
    1
  • grade 5 adverse events
    1
  • any study drug related ae
    1
14 more recorded rows
  • grade 3 4 study drug related ae
    1
  • grade 5 study drug related ae
    1
  • any sae
    1
  • grade 3 4 any sae
    1
  • grade 5 any sae
    1
  • any study drug related sae
    1
  • overall response
    1
  • overall response rate
    1
  • experiencing dose limiting toxicities
    1
  • event free survival
    1
  • complete response
    1
  • response rate
    1
  • adverse events
    1
  • rate of undetected minimal residual disease
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Acalabrutinib's 87 ongoing trials reports first?


87 registered trials of Acalabrutinib are open; earliest completion 2024-03. ClinicalTrials.gov · 2026-09-01

Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1; Incidence of Treatment-Emergent Adverse Events; latest 2033-03-23

Show the evidence

Trial

  • NCT02029443
    "ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia"; n 306; "Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1"; 2027-06-09
  • NCT02157324
    "Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia"; n 12; "Incidence of Treatment-Emergent Adverse Events"; 2026-04-01
  • NCT02180711
    "Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma"; n 113; "Part 1: Incidence of Treatment-emergent Adverse Events."; 2028-12-11
  • NCT02180724
    "An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia"; n 107; "Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria"; 2026-12-31
  • NCT02475681
    "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL"; n 535; "Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B"; 2026-09-15
  • NCT02477696
    "Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)"; n 533; "Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment"; 2028-01-03
14 further recorded trials
  • NCT02586857
    "A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)"; n 24; "Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria."; 2026-04-01
  • NCT02717611
    "A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy"; n 60; "The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)"; 2026-06-06
  • NCT02970318
    "A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL"; n 310; "Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment"; 2027-10-01
  • NCT02972840
    "A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL"; n 635; "Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2"; 2027-02-15
  • NCT03128879
    "Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL"; n 59; "The primary endpoint will be the rate of MRD-negativity in the bone marrow, using an assay method with at least 0.01% sensitivity after 12 cycles of combination therapy. One cycle is 4 weeks of treatment."; 2027-05-31
  • NCT03328273
    "A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"; n 12; "Number of participants experiencing dose-limiting toxicities"; 2026-08-26
  • NCT03516617
    "Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 120; "Rate of minimal residual disease (MRD)-negative complete response (Arm A and Arm B)"; 2030-10-16
  • NCT03571568
    "A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL"; n 140; "Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib"; 2026-09-30
  • NCT03580928
    "Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL"; n 72; "Rate of Bone Marrow (BM) Minimal Residual Disease (MRD) Negative Complete Response (CR) After 15 Cycles"; 2027-12-31
  • NCT03836261
    "Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL"; n 984; "To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS"; 2027-01-31
  • NCT03863184
    "Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL"; n 37; "Peripheral Blood Minimum Residual Disease (MRD)-Negative Complete Response (CR) Rate of the Combination of Acalabrutinib + Lenalidomide + Rituximab at the Conclusion of 12 Cycles of Induction Therapy"; 2028-05-30
  • NCT03868722
    "Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment"; n 212; "Grade 3-Infection-free survival"; 2030-07-31
  • NCT03899337
    "A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome"; n 72; "Randomised Component - Progression free survival (PFS)"; 2028-07-31
  • NCT03932331
    "Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies"; n 105; "Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"; 2026-06-24

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Acalabrutinib could settle lifespan?


NCT02475681 measures Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B, reading out 2026-09-15.

20 open trials; n 535; "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL"

Show the evidence

Trial

  • NCT02475681
    "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL"; n 535; "Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B"; 2026-09-15
  • NCT05950997
    "A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL"; n 89; "Progression-free survival rate at 24 months"; 2026-09-30
  • NCT04075292
    "Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia"; n 155; "Progression Free Survival (PFS) Assessed by BICR"; 2027-01-01
  • NCT04722172
    "A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL"; n 55; "progression-free survival (PFS)"; 2027-02
  • NCT02972840
    "A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL"; n 635; "Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2"; 2027-02-15
  • NCT04529772
    "A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)"; n 611; "Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B"; 2027-02-22
14 further recorded trials
  • NCT05388006
    "Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 27; "Progression free survival"; 2027-02-22
  • NCT05557695
    "Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom"; n 350; "Real-world progression free survival (rwPFS)"; 2027-04-01
  • NCT02970318
    "A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL"; n 310; "Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment"; 2027-10-01
  • NCT06441097
    "Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL"; n 152; "Progression-free survival(by IRC)"; 2027-12-31
  • NCT02477696
    "Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)"; n 533; "Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment"; 2028-01-03
  • NCT04662255
    "Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)"; n 500; "To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)"; 2028-04
  • NCT05197192
    "A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL"; n 202; "Progression-free survival (PFS)"; 2028-05
  • NCT03899337
    "A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome"; n 72; "Randomised Component - Progression free survival (PFS)"; 2028-07-31
  • NCT06319456
    "A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL."; n 344; "Progress Free Survival (PFS)"; 2028-08
  • NCT05057494
    "A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 607; "Progression-free Survival (PFS)"; 2029-04-10
  • NCT03868722
    "Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment"; n 212; "Grade 3-Infection-free survival"; 2030-07-31
  • NCT04604067
    "Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial."; n 260; "Cohorts A, C and D: Progression free survival (PFS) according to the Lugano criteria"; 2030-12
  • NCT07277231
    "A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia"; n 500; "Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)"; 2031-11
  • NCT07377578
    "A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma"; n 394; "Progression-free survival (PFS) assessed by IRC"; 2033-01-30

Which 16 trials of Acalabrutinib posted no result?


Posted no result
16 of 16 completed trials
Registrations
NCT04901923, NCT04914936, NCT04867941, NCT04876807, NCT04898101 and NCT04867980, and 10 more
Completion dates
oldest 2014-05-22; newest 2023-09-26
Show the evidence

Trial

  • NCT04901923
    2014-05-22
  • NCT04914936
    2014-10-16
  • NCT04867941
    2015-02-02
  • NCT04876807
    2016-03-15
  • NCT04898101
    2016-04-13
  • NCT04867980
    2016-05-09
10 further recorded trials
  • NCT04905043
    2016-07-11
  • NCT05140096
    2020-04-15
  • NCT04489797
    2020-08-28
  • NCT04564040
    2020-12-11
  • NCT03527147
    2021-03-31
  • NCT05024006
    2021-04-17
  • NCT04768985
    2021-05-10
  • NCT04094142
    2022-05-15
  • NCT03571308
    2023-08-31
  • NCT03787264
    2023-09-26

At the median, Acalabrutinib's trials enrolled 50.5 people — anything larger?


Median enrolment
50.5
Largest enrolment
15000
Registered trials counted
142

What do 129 spontaneous reports say about Acalabrutinib — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Acalabrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 129 reaction mentions were counted: malignant neoplasm progression 24; atrial fibrillation 20; febrile neutropenia 17; disease progression 15. open-targets-adr · CHEMBL3707348 · 2026-06-24

Show the evidence
  • malignant neoplasm progression
    24
  • atrial fibrillation
    20
  • febrile neutropenia
    17
  • disease progression
    15
  • drug resistance
    15
  • covid-19
    12
4 more recorded rows
  • leukocytosis
    9
  • myelodysplastic syndrome
    6
  • tumour lysis syndrome
    6
  • lymphocytosis
    5

recorded 2026-06-24 · last checked 2026-09-04

Acalabrutinib and CYP3A4, BCRP and CYP1A2: shared by which compounds?


CYP3A4, BCRP and CYP1A2 appear in Acalabrutinib's recorded interaction sentences, 18 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP1A2

  • pharmacokinetics
    Acalabrutinib is an inducer of CYP1A2, CYP2B6, and CYP3A4.
  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP2B6

  • pharmacokinetics
    Acalabrutinib is an inducer of CYP1A2, CYP2B6, and CYP3A4.
  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP2C19

  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP2C8

  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP2C9

  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP2D6

  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

CYP3A4

  • pharmacokinetics
    Acalabrutinib is an inducer of CYP1A2, CYP2B6, and CYP3A4.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inducer of CYP3A4.
  • pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes: Acalabrutinib is an inhibitor of CYP3A4/5, CYP2C8 and CYP2C9, but not CYP1A2, CYP2B6, CYP2C19, or CYP2D6.
  • pharmacokinetics
    Acalabrutinib’s active metabolite, ACP-5862, is an inhibitor of CYP2C8, CYP2C9 and CYP2C19, but not CYP1A2, CYP2B6, CYP2D6, or CYP3A4/5.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Acalabrutinib and IGF-1?


"In order to test for potential off-target effects, second generation BTK inhibitor Acalabrutinib with greater BTK selectivity and lower cardiovascular toxicity was tested for IGF1-mediated activation of intracellular Ca handling." — where Acalabrutinib and IGF-1 appear together. Europe PMC · pathway abstract search · 2023-08-15

IGF-1; PMID 37655217

Show the evidence

IGF-1

  • PMID 37655217
    "In order to test for potential off-target effects, second generation BTK inhibitor Acalabrutinib with greater BTK selectivity and lower cardiovascular toxicity was tested for IGF1-mediated activation of intracellular Ca handling."
  • PMID 37655217
    "Acalabrutinib induced similar effects on Ca handling in IGF-1 treated cultured myocytes as Ibrutinib in regard to decreased Ca transient amplitude and slowed Ca transient decay, hence implying a functional class effect of BTK inhibitors in cardiac myocytes."

recorded 2023-08-15 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3707348
PubChem CID
71226662
CAS number
1420477-60-6
RxCUI
1986808
InChIKey
WDENQIQQYWYTPO-IBGZPJMESA-N
Also called
Acp-196, aca, btki, ACALABRUTINIB MALEATE, Acalabrutinib [INN], Acalabrutinib [JAN], Acalabrutinib [MI], Acalabrutinib [ORANGE BOOK], Acalabrutinib [USAN], Acalabrutinib [WHO-DD]
Salt form
Acalabrutinib maleate anhydrous, Acalabrutinib maleate monohydrate, Calquence maleate
Trade name
Calquence
Sources (10)

Sources

4 more sources
  • open-targets-adr CHEMBL3707348 ·
  • openfda-label b1409184-3267-4d8c-8f17-4e01f69828b1 ·
  • openfda-label+europepmc K1:I42748ELQW ·
  • national registers US, CA ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 10 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.